On 17 June 2020, the decree implementing French Ordinance No. 2017-49 of 19 January 2017 on the benefits offered to healthcare professionals by manufacturers or marketer of health products or services was published in the Official Journal.
About the French "anti-gift" scheme
The Ordinance of 19 January 2017 was amended and ratified by Law No. 2019-774 of 24 July 2019, known as the "Loi ma Santé 2022".
As a reminder, Article L.1453-5 of the French Public Health Code (PHC), prohibits "any person providing health benefits, producing or marketing products covered by compulsory social security schemes or products mentioned in II of Article L.5311-1" from offering or promising benefits in cash or in-kind, in any form whatsoever, directly or indirectly, to all persons exercising a regulated health profession, students who are destined for one of these professions, associations that group them, etc.
Although prohibition is the rule, Article L.1453-7 PHC provides for certain strictly limited exemptions, which are subject to the conclusion of a convention between the beneficiary of the benefit and the person mentioned at Article L.1453-5 PHC. This convention must then be subject to either a declaration or authorisation system.
These provisions were to enter into force "on dates fixed by decree and no later than 1 July 2018".
Decree No. 2020-730 is a useful addition to the "anti-gift" provisions, providing clarifications - late but welcome - on the nature of the conventions, as well as on the declaration or authorisation procedure to which they must be subject to. This is not, however, the final point of this reform, which has left practitioners in a state of uncertainty for more than two years.
Step 1: drawing up the convention derogating from the French anti-gift scheme
The convention governing the granting of advantage must include the following information:
- the identity of the beneficiary and the person mentioned at Article L.1453-5 PHC. In this respect, the decree specifies which natural or legal persons "providing a health service" is concerned by the system;
- the precise purpose of the convention;
- the information allowing to identify the indirect and final beneficiaries who are not signatories to the convention;
- the nature, the individual and the cumulative amount of the benefits; and
- the date of signature of the convention and the period during which the benefits are granted.
Certain supporting documents may also have to be provided.
Step 2: the formalities following the signature of the convention
For conventions below the thresholds: declaration of the convention
If the amount of the benefits does not exceed the thresholds that have yet to be set by order, the convention signed by the two parties must be transmitted by tele-procedure, by the person mentioned at Article L.1453-5 PHC, no later than eight working days before the day the benefit is granted to the competent authority, in other words :
- to the national council of the association concerned (or to the central council concerned for the association of pharmacists) when the beneficiary is a professional, a legal entity or a student following initial training for a profession covered by a health professional association;
- or to the regional health agency in whose jurisdiction the convention was signed, when the beneficiary is a professional, legal person or student other than those mentioned above.
After analysing the declaration, the competent authority may issue recommendations to the parties to the convention. Decree No. 2020-730 provides for a non-exhaustive list of these recommendations.
For the most important conventions: the authorization of the convention
If the amount of the benefit granted exceeds the thresholds to be set by order, the application for authorisation of a convention must be sent, by tele-procedure, by the person mentioned at Article L.1453-5 PHC, to the competent authority, which will decide within two months of the date of receipt of the application. If the file is incomplete, the two-month period runs from the date of receipt of the documents which were missing.
In the event of a refusal, an amended convention may be submitted to the competent authority within 15 days of the notification of the refusal. The competent authority shall then take a new decision within 15 days.
In the absence of reply within the first two months, or within 15 days from the transmission of an amended convention following a refusal, the convention shall be authorised.
In cases of proven urgency, the competent authority shall decide within three weeks and, in the case of a refusal followed by the transmission of an amended convention, within one week.
The decree is due to enter into force on 1 October 2020. However, it is difficult to imagine that it can be fully implemented until the order setting the thresholds above which the convention is subject to an authorisation procedure has been published in the French Official Journal. Let us hope that this order will not be further delayed.